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Leonard G. Gomella, MD, co-investigator of the REDUCE trial, discusses what has been learned from three prostate cancer prevention trials and the future of prostate cancer chemoprevention.
As a specialty, urology is responsible for pioneering large, randomized clinical trials of prostate cancer prevention strategies, in particular the Prostate Cancer Prevention Trial (PCPT), the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, and the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Results of two of the three studies have been positive, although interpretation of the data has been controversial at times. In this interview, Leonard G. Gomella, MD, co-investigator of the REDUCE trial, discusses what has been learned from these pivotal trials and the future of prostate cancer chemoprevention. Dr. Gomella is professor and chairman of urology at the Kimmel Cancer Center of Thomas Jefferson University, Philadelphia. He was interviewed by Urology Times Editorial Consultant Philip M. Hanno, MD, MPH, professor of urology at the University of Pennsylvania, Philadelphia.
Q Please discuss the results of the SELECT trial regarding vitamin E and selenium supplementation when used to decrease prostate cancer risk.
Q Let's talk about finasteride. Why does the use of this relatively inexpensive generic drug remain low in the community despite the finding in the PCPT that it can reduce the risk of prostate cancer for cause by close to 25%?
A A lot of it has to do with the fact that there is really no major proponent for generic finasteride. It has no industry advocate. My understanding is that Proscar came off patent and there's no compelling interest at this time to bring forward a generic version that would have formal FDA approval as a potential prevention strategy against prostate cancer.
The other reason is that when the initial PCPT results came out, it appeared the drug might induce high-grade cancer, which put a scare into everyone.
Q What do you make of the analysis that the improvement with finasteride is lost when you take into account that a disproportionate number of patients on active drug should have undergone biopsy but did not?